Bone MicroArchitecture Abatacept (BMA2)

NCT02675218 | Terminated

• 2 other identifiers: 15082032015-005644-33
• Study Type: observational
• Target: 13
• Locations: 1 country
• Sites: 5

Brief Summary

Rheumatoid Arthritis patients management reposes primarily on the use of disease-modifying antirheumatic drugs (DMARDs). Among DMARDs available in 2015, researchers demonstrated the ability to reduce synovitis, biomarkers of inflammation, and bone destruction. Given the demonstration of correlation between joint inflammation and structural progression at each joint level as well as the opportunity for bone remodeling with resolution of joint inflammation, researchers expect to observe an improvement in bone micro-architecture parameters specifically in rheumatoid arthritis patients without remaining joint inflammation 3 months following abatacept treatment initiation.

Conditions

Arthritis, Rheumatoid

Outcome Measures

Primary Outcomes (1)

• Value of joint inflammation

  The predictive value of persistent joint inflammation on volumetric trabecular bone density is measured by high resolution pQCT (peripheral Quantitative Computed Tomography) after 1 year treatment with Abatacept.

  1 year

Study Arms (1)

Patients with rheumatoid arthritis.

Rheumatoid arthritis diagnosis according to ACR (American College of Radiology)/EULAR 2010 classification criteria.

Other: Patients with rheumatoid arthritis

Interventions

Patients with rheumatoid arthritis OTHER

Doppler effect at 3 months after Abatacept treatment initiation.

Also known as: Doppler effect

Patients with rheumatoid arthritis.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Rheumatoid arthritis patients diagnosed according to ACR/EULAR 2010 criteria, and Abatacept therapy sub-cutaneous required according EULAR recommendation.

You may qualify if:

• Signed and dated informed consent form,
• Age ≥ 18 years,
• Rheumatoid arthritis diagnosis according to ACR/EULAR 2010 criteria
• Abatacept therapy sub-cutaneous required according EULAR recommendations
• Patients affiliated to health insurance

You may not qualify if:

• Other arthritis than rheumatoid arthritis,
• Contraindication to abatacept,
• Concomitant treatment with zoledronic acid (Aclasta®) or denosumab (Prolia®),
• Prior or planned joint surgery at the 2nd or 3rd metacarpophalangeal joint of the dominant hand over the one year study,
• No recent used of high density contrast material,
• Pregnancy or breastfeeding.

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead

Study Sites (5)

Hôpital Édouard Herriot

Lyon, 69000, France

Location

Ch Regional D'Orleans

Orléans, 45067, France

Location

Assistance Publique-Hopitaux de Paris

Paris, France

Location

Chu Saint Etienne

Saint-Etienne, 42100, France

Location

CHU de Toulouse

Toulouse, 31059, France

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples will be performed to determine the predictive value of joint inflammation.

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Doppler Effect

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Physical Phenomena

Study Officials

• Hubert MAROTTE, PhD

  CHU SAINT-ETIENNE

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2016
• First Posted: February 5, 2016
• Study Start: November 10, 2016
• Primary Completion: June 4, 2019
• Study Completion: June 4, 2019
• Last Updated: July 24, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (5)